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All Silicone Sengstaken Blakemore Tube (Type 53)
EUDAMEDClass IIa (EU MDR)
Ref 002 182 5318Ref 002-182-5318
Identity
- Trade Name
- All Silicone Sengstaken Blakemore Tube (Type 53) EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- 002 182 5318 EUDAMED002-182-5318 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187240825 EUDAMED04542187229028 EUDAMED04542187223675 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
All Silicone Sengstaken Blakemore Tube (Type 53) by Create Medic Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4542187000068X | Class IIa | Active |
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Manufacturer
- Manufacturer
- Create Medic Co., Ltd.
- EUDAMED SRN
- JP-MF-000010849
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 9e434cf5-48c2-4c87-a723-73ef3334a922 61 fields · synced Jul 25, 2026
- EUDAMED fa491fe5-54e0-4dfb-9e5e-a2e0a85c4370 61 fields · synced May 19, 2026
- EUDAMED 58134b92-62aa-4e7d-957c-8e27ceaf5e28 61 fields · synced Jul 9, 2026